MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® RUBBER UTILITY CATHETER; RED RUBBER CATHETER

Model Number	277710
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	06/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the patient has had three urinary tract infection in the last 2 months.It was unknown if the device contributed to the urinary tract infection at this time and medical intervention was unknown.Per customer via phone on (b)(6) 2022, customer stated that they did not know whether the urinary tract infections were from catheters or not.And they were prescribed with three different antibiotics, nitrofurantoin, cefdinir and cephalexin, one for each of the urinary tract infections they has had.It was stated that the customer had recovered from urinary tract infections and was fine now.
Event or Problem Description
It was reported that the patient has had three urinary tract infection in the last 2 months.It was unknown if the device contributed to the urinary tract infection at this time and medical intervention was unknown.Per customer via phone on 27jun2022, customer stated that they did not know whether the urinary tract infections were from catheters or not.And they were prescribed with three different antibiotics, nitrofurantoin, cefdinir and cephalexin, one for each of the urinary tract infections they has had.It was stated that the customer had recovered from urinary tract infections and was fine now.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "patient sensitivity to materials".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "rubber utility catheter x-ray opaque rubber warning: do not use ointments or lubricants having a petrolatum base.They will damage latex.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Caution: this product contains natural rubber latex which may cause allergic reactions.Caution: federal (usa) law restricts this device to sale by or on the order of a physician.For urological use only.U.S.Product.Packaged in mexico." h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

• Brand Name: BARD® RUBBER UTILITY CATHETER
• Common Device Name: RED RUBBER CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14936725
• Report Number: 1018233-2022-05221
• Device Sequence Number: 4995078
• Product Code: KOD
• UDI-Device Identifier: 00801741034084
• UDI-Public: (01)00801741034084
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2026
• Device Model Number: 277710
• Device Catalogue Number: 277710
• Device Lot Number: NGFY3787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown